Injectable Vascular Access Port with Discernable Markers for Identification

ABSTRACT

An improved injection port identification for injection ports implanted under the skin of a patient. The injection port has an x-ray discernable marker allowing for the determination of a pressure rating for the injection port when so implanted. A plurality of concurrent visual, RF, light emitting and sonic means for signaling the port&#39;s pressure rating are also employable to provide multiple concurrent affirmations of the port&#39;s readiness for high pressure injections.

This application is a Continuation in Part of U.S. application Ser. No.12/700695 filed on Feb. 4, 2010 which claims the benefit of U.S.Provisional Application Ser. No. 61/149967 filed on 4 Feb. 2009, bothherewith included in their respective entirety by this referencethereto.

FIELD OF THE INVENTION

The disclosed device relates to power-injectable vascular access portswhich are implanted in a patient and conventionally employed for poweredinjection of medicine and medical related injectables such as during aninjection of contrast media for a CT scan. More particularly, it relatesto such a vascular access port which provides users one or a pluralityof pressure rating markers which may be X-ray discernable, audible,discernible using RF energy for digital reporting, or through visualobservation of the skin. Pressure rating is determinable using one or aplurality of the discernible markers to ascertain the port itself israted for powered injection under high pressure.

BACKGROUND OF THE INVENTION

Intravenous therapy or IV therapy is the giving of liquid substancesdirectly into a blood vessel. Such therapy may be intermittent or may becontinuous and during the therapy a fluid conduit must be establishedinto the vascular system of the patient and maintained.

The simplest form of intravenous access is a syringe with an attachedhypodermic needle. The needle is inserted through the skin into a bloodvessel, and the contents of the syringe are injected through the needleinto the bloodstream. Since direct injection only allows for thedelivery to a patient of a single dose of medication, where prolongedtherapy using multiple doses is to the regimen, a more popular modeemploys a peripheral IV line consisting of a short catheter (a fewcentimeters long) inserted through the patient's skin into a sealedengagement with a peripheral vein. A body or hub in sealed communicationwith the axial passage of the catheter is engaged on the distal end ofthe catheter and remains outside the patient's body, usually on the skinsurface. In this position the hub can be connected to a syringe or anintravenous infusion line to communicate fluid to the bloodstream of apatient, or capped when not in use. The hub and engaged catheter thusallows for multiple treatments with the same line.

However, on many patients a more direct route to the central bloodvessels is required for provision of medication, treatments, andinjections employed during X-ray and other imaging. Conventionally, acentral venous line provides access for this purpose and consists of acatheter being inserted into a subclavian, internal jugular, or (lesscommonly) a femoral vein and advanced toward the heart until it reachesthe superior vena cava or right atrium. Because all of these veins arelarger than peripheral veins, central lines can be employed to deliver amuch higher volume of fluid and can also have multiple lumens feedingthe central line.

Implantable ports are a type of central venous line which does notemploy an external connector positioned outside the patient's body.Instead, such implantable ports have a small reservoir which is coveredwith a flexible cover and the entire device is implanted under the skinof the patient.

A catheter or other means for sealed communication of a lumen between ablood vessel and the reservoir, communicates between an outlet of thereservoir and an internal blood vessel such as a vein. Often, a rigidcap or similar capping means is employed with the communication means tofurther secure the distal end of the catheter to the reservoir outlet.Such a cap known in the art is typically a small cylindrical member thatis slidably and coaxially engaged upon the lumen or catheter enhancingthe coaxially fictional engagement of the catheter to the outlet. Inuse, the rigid cap is slidably engaged upon the catheter surface bysliding it over the catheter which is engaged around the outlet. A forceimparted circumferentially to the catheter by the cap, sandwiches thecatheter between the cap and the conduit over which it engages andthereby acts to further bias the catheter against its contact with theoutlet, and securely engage the catheter to the outlet exterior surface.

Once so implanted, medication may be administered to the patientthereafter by communicating a small huber needle through their skin,piercing the septum or flexible cover of the port, and injecting themedication directly into the reservoir under the flexible cover providedby the septum. When the needle is withdrawn, the reservoir cover, whichis formed of a material which reseals, seals itself.

Since the septum formed by the implanted port reservoir cover can accepthundreds of needle piercings during its lifetime, it is possible toleave the port in the patient's body for years. This semi-permanentimplantation under the skin, helps avoid infection by leaving the skinbarrier intact. Further, over time employment of the implant is muchless painful to the patient since they need not endure pokes and needlesticks and the incision generally required by exterior mounted ports.

However, a particular problem occurs for medical professionals duringthe implantation process with many conventional ports. During assembly,the secure engagement of the reservoir outlet to the catheter can beparticularly troublesome. This difficulty is caused by the relativelysmall size of the cap which must be held by the gloved hand of themedical professional. It is often difficult to grip the small cap andslide it along the catheter and over a sealing bulge in the outletconduit to correctly and securely engage the cap circumferentiallyaround and to the catheter which itself is engaged to the tubularconduit providing the outlet. The friction of the catheter against theinside circumference of the cap can cause the cap to slip from theuser's fingers.

The problem is further exacerbated because the professional is wearinggloves, and the cap and catheter can become wet and slippery. Thiscombination of circumstances often causes the medical professional todrop the cap which becomes non-sterile on landing, wherein it must beimmediately discarded. This problem is sufficiently prevalent that somemanufacturers provide a plurality of caps with the kit of theimplantable port.

If the medical professional is able to correctly engage the cap over andonto the catheter and secure it to the tube forming the outlet, there isan additional problem which occurs when implantable ports are to beinfused using power injection. Such infusions communicate the liquidinto the reservoir of the implanted port, under high pressure, in orderto move a large amount of liquid into the body of the patient in a shorttime. Such powered injection devices communicate fluid at high pressurelevels through the septum covering the reservoir of the implantedinfusion port which must be rated to handle the high pressure or theport could malfunction. The user must ascertain before such a highpressure injection, that the implanted port is rated for the anticipatedhigh fluid pressure or a rupture of the port and related seriousproblems will occur.

Because the implanted port is positioned under the skin of the patient,conventionally there is no means for the professional to visuallyinspect it and ascertain a pressure rating during and after use.Consequently, it can be a vexing task for medical personnel to ascertainif in fact an implanted port is rated for high pressure and thecommunication of a high volume of the anticipated infusion to be giventhe patient. Hidden from view by the patient skin layer, it isconventionally not possible to examine the implanted port prior to useand ascertain visually the port is rated for the upcoming procedure.

However, because of the potential for patient harm should a ruptureoccur, most medical protocols require two independent means ofascertaining the implanted port is high-pressure rated. The dualconfirmation must be ascertained prior to using the port during asubsequent high pressure injection through the septum covering thereservoir of the port. Currently, one means to ascertain the portpressure rating is to read the patient's chart which may be marked withthe pressure rating on the hidden port. Another means is to look for andread exterior identification means where the patient may wear an IDbracelet, or other means to denote that the implanted port is rated tothe pressure to which it is about to be connected.

However, there is currently no means for visual confirmation of theimplanted and skin-covered port's pressure rating by an inspection ofthe implant site by the medical professional. Consequently, they mustdepend upon the accurate charting and labeling by themselves and byother workers. With charts and bracelets being known to be less thanaccurate on occasions, or in cases where a chart indicates one pressurerating and a bracelet indicates another, it would be especially helpfulto provide one or a combination of alterative means to ascertain thepressure rating of an implanted port. In cases where the records andcharts disagree, multiple alternative pressure determination means wouldalso prevent needless patient procedures to remove or replace implantedports when two means of identification cannot be found. Further, all ofthis confirmation required slows the progress of CT scans for thepatient which costs the medical facility valuable time where the scannerby be employed elsewhere.

As such, there exists a continual unmet need, for a means for medicalprofessional to identify that an implanted infusion port, hidden by skinand other patient tissue, is actually rated for the high pressure usefor which it is about to be employed. Such a means of identificationshould be easy to employ, and allow for the use of the installed base ofmedical equipment already in hospitals and medical offices to lowercosts and insure widespread easy deployment. Such means foridentification should ideally provide a plurality of means to ascertaina high pressure rating on the implanted port to allow the medicalprofessional to choose a favorite or supplement another determinablemeans on the port.

In addition to the need to better identify the ports pressure ratings,there is a further unmet to need for an improved means for engaging thecap member to the catheter to insure its secure engagement to the outletconduit of the port. Such an improved securing means should employ asimilar procedure as the current cap engagement to the catheter tothereby encourage use by not requiring the learning of a new skill.Further, such an improved engagement should eliminate the dropping ofconventional clips and the need to provide multiple clips for thateventuality and to provide an improved gripping means for the cap thatwill more easily allow the user to grasp it even while wearing gloves.

With respect to the above, before explaining at least one preferredembodiment of the invention in detail or in general, it is to beunderstood that the invention is not limited in its application to thedetails of construction and to the arrangement of the components or thesteps set forth in the following description or illustrated in thedrawings. The various apparatus and methods of the invention are capableof other embodiments, and of being practiced and carried out in variousways, all of which will be obvious to those skilled in the art once theinformation herein is reviewed. Also, it is to be understood that thephraseology and terminology employed herein are for the purpose ofdescription and should not be regarded as limiting.

As a consequence, those skilled in the art will appreciate that theconception upon which this disclosure is based may readily be utilizedas a basis for designing new X-ray or fluoroscope discernable markers,and combinations of other visual, sonic, and RF enabled markers,allowing for a power and a pressure rating verification of implantedinfusion ports and the like, and for carrying out the several purposesof the present disclosed device and method. It is important, therefore,that the embodiments, objects and claims herein, be regarded asincluding such equivalent construction and methodology insofar as theydo not depart from the spirit and scope of the present invention.

SUMMARY OF THE INVENTION

The marker device allowing the identification method herein is employedin combination with an injection port (or portacath) which is a smallmedical appliance that is conventionally installed beneath the skin.Such ports are designed for implantation under the skin of a patient andthe port employs a septum or membrane cover on an upper surface closestto the patient's skin. This septum or cover provides a self-sealingmeans to communicate with an underlying reservoir and is adapted to bepierced by a needle or other means to communicate medicine and drugsinto the underlying reservoir or for the taking of blood samplestherefrom on numerous occasions.

The marker device allowing for identification of the implanted port, isengaged to, or within, the implanted port and is formed of a materialsuch as nitenol or tungsten or titanium, or stainless steel, or othernon-ferrous metal which can easily be discerned on a CT scan or X-ray oron a fluoroscope. In a preferred mode, the marker is placed within thereservoir of the port. Such as location is preferable in that there isknow chance of the marker be scraped off or otherwise damaged duringinstillation or removal within a patient.

In other preferred modes however, the marker device may be any X-raydiscernable material such as a high density ceramic, or X-ray excitablepolymer. The marker may be a planar piece of material that is positionedwithin the interior of the reservoir, or upon the exterior of the septumcover or implanted port, or it may be a piece of the preferreddiscernable material which is free floating within the reservoir cavitywithin the implanted port. Other materials which will be substantiallydiscernable on an x-ray, may be employed such as ink infused withmetallic material such as a high density ceramic, an x-ray excitablepolymer, titanium, stainless steel, or other non-ferrous metal and whichmay be imparted to an interior or exterior surface of the implantedport. Still further, the marker device formed employing such an ink mayalso be imparted on the conduit, septum, or for ease of reading withoutthe port body obscuring it, the marker may be positioned on the conduitcap of the implanted port.

It is most preferred that a visual marker employ a non-alphanumericidentifier because some technicians may have trouble reading letter andnumbers indicating pressure ratings. Further, such ports are employed inmany countries with many languages, and the use of letters and words inone country may not be understandable in another. Still further, in somecountries, x-ray technicians may not be able to read at all and the useof letters or number designators will not provide information to suchusers that a simple symbol can.

It is preferred therefor that the symbol be singular in nature so as notto be confusing and a simple shape that is easily discerned. A currentpreferred symbol is that of a triangle as rectangles and multiple sidedfigures are easily confused when reading them. A triangle on the otherhand is the only three sided shape, is readily identifiable bytechnicians who read, and those that are illiterate.

In use, the metal triangle is placed free floating in the reservoir as asimple universal marker to identify an implanted port as high pressurerated. During a CT scan, which concurrently requires the injection of alarge volume of liquid by a power injection under high pressure, themedical professional performing the procedure, even if illiterate, caneasily first ascertain if the implanted port has the high pressurerating required for the procedure. The user can do so quickly by simplytaking a quick X-ray of the patient in the vicinity of the implantedport. If the port is pressure rated for the procedure, the triangleshaped formed of the material which will show on the X-ray, will beeasily discernable on the X-ray as engaged to or within the plasticimplanted port. This will provide one visually discernable positiveaffirmation as to whether the port is or is not pressure rated for theupcoming procedure.

In another particularly preferred mode, the identification marker isimparted on the cap member in its engagement on the catheter. The clipor cap member in this mode is formed larger for two reasons. First alarger surface area provides an area to print or form the triangle orother x-ray discernible symbol is a reasonably large fashion.

A second reason for the larger cap member is the provision of one or aplurality of finger engageable recesses or ridges formed on the surfaceof planar members extending from and communicating with the typicallycylindrical cap body.

The planar members extending from the catheter engaged clip add utilityin a number of ways. First, the planar protrusions provide a largesurface to allow the user to better grip the cap between finger andthumb, when engaging the cap to catheter as described previously.Further as noted, the larger surface of the planar members provide adistinguishable location at or near the implanted port to impart theidentification marker ink.

As an additional safety protocol, the software which controls the CTscan or other X-ray procedure may be programmed with image recognitionprogram to be employed prior to the procedure moving forward. In thismode, the scanner or x-ray machine would be adapted to initially seekout the port and identify the marker in an initial scan of the patientbefore allowing the medical professional to continue with the procedure.Once identified by software adapted to recognize acceptable identifiersengaged to the port, a microprocessor will allow the employment of thenext procedural step which would involve a powered injection to becommunicated through the cover and into the reservoir of the port underhigh pressure.

Still further, the markers so engaged to or near the port, may be crossreferenced with a database of pressure ratings. This would allow for theemployment of multiple ports with higher and lower pressure ratingswherein a triangular shape for example would verify on pressure ratingand a rectangular shape would verify a different pressure rating.

Even further, another identification marker may be employed in the formof a Radio-frequency identification (RFID) transponder. The technologycan be used for automatically identifying the port as high pressure orotherwise. The relatively small RFID employing combined radio receiverand transmitter, or employing other audio or visual means for reporting,will thereby communicated identity information over a short distance,when energized by a detector placed close to the RFID antennas.

When configured to transmit a message, the RFID when energized by the RFfield placed proximate to its antennas, will transmit numbers and/ortext held in memory. The transmissions from an energized RFID can beread from several meters away and beyond the line of sight of thereader. The RFID tags can be programmed and hold information such as theport serial number, brand, install date, and pressure rating, during themanufacturing process. Thereafter, when implanted in a patient incombination with a pressure port, the RFID when energized by a readerdevice or other means of RF generation of sufficient power to energizethe RFID, will transmit the stored information such as the noted serialnumber and high pressure rating along with other stored information.

Using an interface and software adapted to the task, this informationcould be automatically logged to a patient's chart, and/or can beemployed in combination with software controlling the pressure pump, toenable the high pressure pump only when a high pressure rating isdetermined.

In an additional favored mode of the device herein, in addition to theRFID when energized, there may also be operatively engaged with theRFID, or independently activated or operated, one or both of an audio orvisual reporting component, which will provide sonic and or visualaffirmation when activated by either an RFID scanner or other means toactivate an audio or visual report from outside the body of the patient.In this mode of operation, alone, or in combination with the RFtransmission of data above, a electronic sound generator or beeper, oreven a speaker capable of synthetic speech, can be also energized tomake a sound discernible through the skin which would provide a sonicsignal discernible by medical professionals without computers or x-rays,that the port is high pressure. Such a simple sound-based confirmationwould be extremely useful in medical facilities without an x-ray but aneed to use high pressure ports on patients. In addition to theelectronic sound generator such as a buzzer or beeper, a small speakerengaged with an amplifier on the RFID or engaged with it, and a memorychip holding speech sounds in ROM, could combine to speak the words“high pressure” when the RFID is energized.

As noted, another mode of pressure port pressure from the exterior ofthe patient body is an LED operatively engaged to illuminate when theRFID circuit is energized. Such products are commercially available forinstance from the Montie Design. LED's exist which are tremendouslybright at low power and capable of illumination independently with theirown remotely located operation component or concurrently when the RFIDcircuit is energized by RF energy sufficiently to be seen through theskin of the patient. From a small red dot visible through the skin to aseries of LED's which render a red triangle through the skin, thisvisible means to determine a high pressure rating also needs no x-ray toprovide the medical technician with confirmation of high pressureratings. A light transmitting LED also would work well in instanceswhere an X-ray is not convenient. It would also be preferred in somecases to employ a signaling scheme with the LED illumination. This canbe in a similar fashion to Morse code where the LED will illuminate aspecific number of times to confirm high pressure which will eliminatethe possibility a manufacturer of a low pressure port might have anilluminating LED upon it could be mistaken. A set number of individualilluminations and darkenings signifying high pressure, such as threeblinks, would be desirable. Further, both the sonic reporting and LEDreporting, could also be used to simply save power and machine-use ofthe x-ray machine or CT scanner to simply ascertain the port rating. Inthis fashion, the CT scanner or x-Ray need not be employed since theLED, Sonic generator, or RFID, in combinations would provide a dualconfirmation of the presence of a high pressure port. Further, with anRF transmission, or light through the skin, or sound transmitted throughthe skin, the user has three independent means to ascertain a highpressure rating of the implanted port.

The ability to view a marker engaged to or upon the implanted port orreceive port information via transmitted data, sound, or light fromLED's controlled in concert with energized RFID's, will thus provide aplurality of independent means to determine a proper pressure rating ofthe port. A sound can be generated, a light stream or plurality ofblinks visible through the skin can be initiated, or an RF message canbe transmitted and displayed on a computer screen. All three modesindependently confirming that an implanted port, hidden under thepatient's skin, is rated for the pressure to which it will be exposed inan upcoming procedure.

Yet another mode of visual confirmation of high pressure rating isavailable using another mode of the device herein wherein the RFIDemploys RF antennas which are shaped as triangles, or other easilydiscernable shapes which signify a high pressure port. The triangle ofthe antenna is metallic and will appear very distinct on an x-ray,thereby verifying using a symbol that the port is high pressure rated.The triangular antennas, the LED, the data transmission from the RFID,the sound transmitted, and the triangular member positioned on the clip,form a group of identifiers which all be employed singularly, or incombinations of all or any individual member of the group with anyother, to provide one or a plurality of individual identifiers for ahigh pressure port. Further, it is anticipated that they may be usedalone or in combination with the physical markers provided by atriangular metal member positioned in the reservoir of the port, orpositioned on the clip engaged to the catheter o the port. Thisemployment of icons and shapes such as a triangle will also allowtechnicians in countries where reading may be a challenge, and easymanner to visually confirm the presence of a high pressure port.

Further, in all preferred modes it is additionally preferred that theRFID may include a wideband transmission antenna element to allow theRFID and or a second transmitter to singularly or concurrently broadcaston multiple frequencies such as needed for bluetooth and WiFi. As theRFID is read or energized with a scanner, the transmitted informationsuch as port serial number, brand, lot, manufacture date, install date,and pressure rating may be transmitted to a physicians electronicdatabase and/or computer screen such that the information can bevisually displayed. If the device employs an antenna capable ofconcurrent broadcasts in multiple frequencies a plurality of electronicinput needs may be met such as broadcasting on bluetooth to inputinformation to the patient chart, and wifi to transmit the informationto a remote physician or medical database being served by a wirelessrouter.

The foregoing has outlined rather broadly the more pertinent andimportant features of the device and method herein employing X-raydiscernable markers upon or within implantable ports in order that thedetailed description of the invention that follows may be betterunderstood so that the present contribution to the art may be more fullyappreciated.

Additional features of the invention may be described hereinafter whichform the subject of the claims of the invention. It should beappreciated by those skilled in the art that the conception and thedisclosed specific embodiments may be readily utilized as a basis formodifying or designing other X-ray discernable marking systems forimplanted ports for carrying out the same purposes of the presentinvention. It should also be realized by those skilled in the art thatsuch equivalent constructions and methods do not depart from the spiritand scope of the invention as set forth in the appended claims.

In this respect, before explaining at least one embodiment of theinvention in detail, it is to be understood that the invention is notlimited in its application to the details of construction and to thearrangement of the components set forth in the following description orillustrated in the drawings. The invention is capable of otherembodiments and of being practiced and carried out in various ways.Also, it is to be understood that the phraseology and terminologyemployed herein are for the purpose of description and should not beregarded as limiting.

THE OBJECTS OF THE INVENTION

It is, therefore, an object of the present invention to provide acomputer displayed visual means to determine if an implanted andskin-covered port is power-rated for engagement to high pressure.

It is another object of this invention to provide such a device andmethod that may be easily incorporated into existing implantable portsand be identified with the installed base of medical equipment atmedical facilities.

It is yet another object of this invention, to employ one or a pluralityof such identifiable pressure rating markers which may be identified bya computer running software adapted to the task and thereby preventaccidental injection in a subsequent step if the proper pressure ratingis not discerned.

It is still another object of the invention to provide a failsafemechanism for determining the two means of pressure identification,wherein if the two means are not ascertained, the CT scan and/or powerinjection will be deactivated.

It is yet still another object of the invention to provide a conduit capemploying finger engageable gripping means and sized to hold symbolsidentifying the high pressure port.

Another object of the invention is to provide one or a combination ofnonferrous metal, high density ceramic, teflon, or other x-ray excitablepolymer identification marker which are easily discerned from thesurrounding port body.

A further object of the invention is to provide a non ferrous metal,high density ceramic, x-ray excitable polymer identification marker inthe form of one or a combination of alphanumeric characters orsymbols/icons imparted on one or a combination of the body of the port,the cap, or the conduit.

Still another object of the invention is to provide a RFIDidentification marker imparted on one or a combination of the body ofthe port, the cap, or the conduit.

A still further object of the invention, is the provision of aconcurrent means of multiple determination of the presence of a highpressure port using one or a plurality of a wireless, a visual signaland/or a sonic signal which identify the port as high pressure and whichmay be discerned through the user's skin.

Yet another object of the invention is the employment of discerniblesignals and figures which may be discerned by a reading-challenged staffwhich allow them to identify a high pressure port without the need toread.

The foregoing has outlined some of the more pertinent objects of theinvention. These objects should be construed to be merely illustrativeof some of the more prominent features and applications of the intendedinvention. Many other beneficial results can be attained by applying thedisclosed method and device in a different manner or by modifying theinvention within the scope of the disclosure. Accordingly, other objectsand a fuller understanding of the invention may be had by referring tothe summary of the invention and the detailed description of thepreferred embodiment in addition to the scope of the invention definedby the claims taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and form a part ofthis specification, illustrate embodiments of the invention and togetherwith the detailed description, serve to explain the principles of thisinvention.

FIG. 1 depicts a perspective view of the device herein engaged to, orfloating within an interior cavity or the reservoir of an implanted portshown in dotted line.

FIG. 2 depicts an X-ray of the device of FIG. 1 wherein the marker isrendered visible by a human or computer with operative recognitionsoftware, within the implanted port, and showing the device positionedwithin a reservoir under the septum.

FIG. 3 depicts graphically a method of implementation of the device in amethod to prevent high pressure injections to ports not recognized ascapable of handling the intended pressure.

FIG. 4 shows an perspective view of a preferred mode of the devicewherein a finger engageable cap member having protruding planar membersemploys the identification marker.

FIG. 5 shows a top view of the device of FIG. 4 in another preferredmode wherein the identification marker is imparted on the septum, alsoproviding a substantially larger finger engageable cap member

FIG. 6 shows a bottom view of the device of FIG. 4 in still anotherpreferred mode wherein the identification marker is imparted on thebottom surface.

FIG. 7 shows still yet another particularly preferred mode of the deviceemploying a dual port system with the identification marker imparted onthe body of the port.

FIG. 8 shows a mode of the device employing an RFID reader/energizer toelicit a data transmission from the RFID engaged with the device on theport body or catheter engaged clip.

FIG. 9 depicts an energizable RFID configured to report electronicallyand a means to illuminate through the skin such as an LED visiblethrough the skin and or activate an sonic alarm such as a buzzer orbeeper.

FIG. 10 shows and RFID, employable on the body of the device or clip,having antennas configured in segments to yield an x ray discernibletriangular shape which would be visible on X-ray to identify the port.

FIG. 11 shows an overhead view of a port device employing a clip engagedupon the catheter having an RFID positioned for less interference of thebody of the port during energizing as in FIG. 9 and a triangular markerthereon.

FIG. 12 depicts a port device having an RFID such as that of FIG. 9having one or both antennas configured with segments yielding thedepiction of triangles which are visible on X-ray to confirm pumppressure ratings which as with others can be on the clip or the body.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings 1-12, wherein similar parts of theinvention are identified by like reference numerals, the device 10 asshown in FIG. 1 is seen having a symbol shaped marker 16 engaged to, orpreferably floating within an interior cavity 12 of the body of a port14 shown in dotted line. The marker 16 formed of metal such as stainlesssteel or one of the other noted discernible markers individually or incombination of the device 10 will be produced in combination with a highpressure port 14 and deployed in a conventional sterile container forimplantation. Such other materials which are highly discernible from thesurrounding tissue and polymeric material forming the port and/or theseptum, are those that are excitable by x rays such as ceramics such asgadolinium oxysulfide, and in particular silicone nitride, Zirconium andzirconium Oxide and synthetics such as teflon.

An elongated conduit forming the outlet 15 of the port 14 is engageableto a catheter 23 or other device providing a lumen which is placed insealed communication with a blood vessel of the patient. Any suchimplanted port 14 may employ any or all of the discernible markersenabling an identification of the device 10 herein as a high pressureport. The metal or other material discernible easily from the plasticbody, such as a member marker 16 is engaged by the inclusion of themarker 16 in an engagement to the body 18 of the port 14, or morepreferably by a positioning within an interior cavity 12 of the port 14which will not require adhesive or heating or other engagement meansthat could damage the wall or other surfaces of the high pressure port.Such positioning without attachment provides a means to protect againstan accidental damaging of the walls forming the port or its parts whichmust maintain high pressure capability.

As noted the marker 16 is best formed of a metal or another materialthat is easily visually discernable from surrounding plastic material ofthe device, by the eye of a viewer of an X-ray as shown in FIG. 2. Suchmaterials may include one or a combination of marker materials from agroup including non ferrous metals such as nitenol, tungsten, titanium,stainless steel, and synthetic or ceramic materials such as teflon,silicone nitride, Zirconium, gadolinium oxysulfide or inks formed of abio-compatible carrier containing one or a combination of the x-raydiscernable materials noted herein which may be printed or adhered tothe port 14, or other materials which will contrast with surroundingtissue and port materials to show on an X-ray.

In a preferred mode of the invention, the marker 16 may be a formed froma solid piece of metal material in a non-letter symbol. In other modesit may be painted or appliqued to the port 14 carefully so as to notdamage it during manufacturing or long storage.

Additionally should the port 14 have multiple pressure ratings fordiffering procedures, indicia indicating the pressure rating for theport 14 may be included in the marker 16, or the marker 16 itself may beshaped differently such as the triangle marker 16 indicating a highpressure rating or a rectangular shaped marker 17 indicating a differentpressure rating, each of which are cross referenced to a specificpressure rating. As noted above, it is preferred that the marker 16 be asymbol so the user need not have to read or discern any letters ornumbers or language and risk mis-reading, or be unable to read them.Further, because a symbol is recognizable without a need for translationor reading ability, it is employable as a marker in any country, and anymedical facility no matter the local language or ability of thetechnicians to read.

Positioned unattached within the body of the port 14, the marker 16identifying the disclosed device 10 in combination with a port 14, willbe clearly visible on an X-ray 17 as shown in FIG. 2. In one mode inFIG. 2 the marker 16 is engaged to the body 18 of the port 14 and inanother image in the X-ray the marker 16 is shown floating within aninterior cavity 12 below the septum 20 through which a needle penetratesto communicate an injection of a volume of fluid under high pressure tothe port 14 in a medical procedure such as a CT scan. This floating modeallows for inclusion of the marker with the device, without the need toattach it and risk damage from heat, inks, or corrosion during long termstorage as might occur if welded on, heated on, or glued onto thedevice.

As depicted FIG. 3 a method of implementation employing the marker 16 isshown providing a means to prevent high pressure injections to ports notrecognized as capable of handling the intended pressure may be employedwith the device 10. As noted the software running the CT scanningdevice, or other X-ray device, or running on the medical facilitycomputer system, may be adapted for use during medical procedures whichrequire a positive identification of a high pressure rated port 14.

The software will employ the scanner to run an initial scan of thepatient and use image recognition software to ascertain the presence ofthe marker 16, prior to allowing the technician to inject the port 14under high pressure in a second step. Because the port 14 is easilyvisually identifiable for pressure rating based on the marker 16 or 17discerned, multiple ports 14 with multiple pressure ratings might be usewithout worry. Since ports 14 which must survive higher pressuresgenerally cost more, the employment of markers 16 or 17 in solid orprinted format which provide visual confirmation of the rating of thehidden port 14, will allow for less expensive ports 14 to be employedwhere subsequent pressures are anticipated to be lower.

If the software mode of the method herein is employed, the CT Scanner orother software and wireless adapted device would in a first step take aninitial scan and employ visual recognition software to discern shape ofthe marker 16 or 17. In a second step the software adapted to the taskand running on a microprocessor, using the discerned shape, willcalculate if the shape discerned is the shape employed to designate anacceptable high pressure-rated port. If the proper port is ascertainedas present, the injection would be permitted. Software controlled lockscan be employed to lock out the high pressure injection untilconfirmation is ascertained of the port.

If more than one shape of the identifier is employed on multiple ports,due to multiple ratings on multiple ports, the software andmicroprocessor would use the initial scan to ascertain the identifierpresent, and the would then match the ascertained shape of theidentifier in the patient, to a relational database of identifiershapes. Using the match, the shape as related to a predeterminedpressure rating for ports bearing the recognized identifier will bedetermined. Once the identification of the port imaged is determined,the procedure would only be allowed to proceed to the high pressureinjection, if the proper pressure rating is discerned from the discernedidentifier ascertained from the data regarding its rating which isaccessed by the software in the identification step with a relationaldatabase.

FIG. 4 shows an additional preferred mode of markers in combination witha single port 14 yielding a device 10. In the figure there is depictedthe port 14 and fluid communication means such as a catheter 34 orsimilar lumen engaged. The catheter 34 is shown employing a particularlypreferred cap 21 of this invention which is secured to the catheter 34to aid its engagement to the outlet 15. As mentioned previously aconventional cap (not shown) is typically a small and hard to handlecylindrical body coaxially and slidably engaged over the catheter 34 andis used to further secure the distal end 35 of the catheter 34 to theoutlet 15 of the port 14.

The preferred cap 21 of the present invention however, employs one or aplurality of projecting members 22 engaged to and communicating with acylindrical body 25. The projecting member 22 provide a large surfacearea as a means to grip and maneuver the cap 21 such as with the thumband forefinger (not shown). Further the surface of the planar member 22may be employed as a mount for an identification marker 23, such aslettering shown, or using symbols such as a triangle as noted above toallow wider use in different countries. Materials for the marker wouldbe those yielding a high contrast from surrounding tissue and plastic.

The marker 23 in this mode may be inlayed solid metal or ink infusedwith one or a combination of marker materials from a group including anonferrous metal such as nitenol, tungsten, titanium, stainless steel,and synthetic or ceramic materials such as teflon, silicone nitride,Zirconium, gadolinium oxysulfide or inks formed of a bio-compatiblecarrier containing one or a combination of the x-ray discernablematerials noted herein high density ceramic, or an x-ray excitablepolymer or plastic such as teflon, which will yield a contrast on anx-ray with the surround material.

Such a marker 23 will be easily distinguishable in an MRI or x-ray bybeing adjacent to the thicker body thereby providing a means to identifythe port 14 as high pressure or otherwise. The maker 23 of such materialmay include alphanumeric characters, or preferably non alphanumericsymbolic marker 16, 17 such as a triangle shown previously. Bypositioning the marker on the cap, which provides a means to anchor thehigh pressure catheter to the body, the risk of damaging the plasticwalls of the body is eliminated as is the risk of damage from long termstorage with inks applied to the body of the device. As noted, themarker 23 may be applied using one or a plurality of the aforementionedx-ray discernible materials yielding high contrast from surroundingmaterials.

FIG. 5 shows a top view of a device 10 of FIG. 4 however in anotherpreferred mode wherein the infused ink alphanumeric or a symbolic oriconic marker 23 is imparted on the septum 20 of the port 14 alone or incombination with such on the body of the catheter 34. The marker wouldbe as with all markers herein, formed of one or a combination of theaforementioned marker materials. It must be noted that the modecurrently shown as well as the other modes disclosed may be employedseparately or in combination with one another and should therefor not beconsidered limiting by the figures.

Further shown in the FIG. 5 is yet another preferred mode of the capmember 21 wherein the cap 21 is a substantially planar body 26 employinga finger ingressable recess 28 providing means to better grip the cap 21for operative employment as described previously. The cap 21 is shown inthe engaged as used mode, engaged to the catheter 34 and wherein thedistal end 35 of the catheter 34 is engaged to the outlet 15 of the port14 while the cap 21 is additionally frictionally and slidably engagedover and providing a compression toward the catheter-engaged outlet 15.

A still further means for identification of the port 14 is provided viathe employment of an electronically activated tag having an RFID 24shown engaged to the cap 21. The RFID 24 employed concurrently with anRFID reader 41 which will allow a medical professional to merely scanover the users chest or other probable location of the port 14 andreceive port 14 information transmitted via radio frequency (RF). Suchinformation may include, but is not limited to, the port serial number,install date, and the pressure rating. As shown in FIG. 8, such radiofrequency information may also be received by Wi-Fi, bluetooth, or othertransmitted means to communicate directly with a computer or the CTscanner or power injector as a fail safe means. For example, if RFIDreturns that the port 14 is not high pressure rated, the CT or injectorwill remain locked and deactivated. This is commonly referred to as a‘Go, No-go’ type failsafe system.

It is within the scope of the present invention that the infused inkalphanumeric marker 23, may be formed of one or a combination of markermaterials, from a group of marker materials including non ferrous metalssuch as nitenol, tungsten, titanium, stainless steel, and synthetic orceramic materials such as teflon, silicone nitride, Zirconium,gadolinium oxysulfide or inks formed of a bio-compatible carriercontaining one or a combination of the x-ray discernable materials notedherein, and be imparted on the body 18 of the port 14 such as shown inFIG. 6. In the figure, the marker 23 provides a first means to discern apressure rating and the RFID 24 provides another means to discern apressure rating. The marker 23 is carefully imparted on the bottomsurface 19 of the body 18.

Again, it must be noted that, the marker 23 may preferably instead be aniconic or symbolic marker 16, 17 such as a triangle as previously shownand formed as noted above from the marker materials group. A symbolicmarker is more readably and positively discernible by nonreaders andeven by readers since they may be sight impaired or without theirreading glasses.

Shown in FIG. 7 is yet another preferred mode of the device 10 employinga dual system port 30 having a bifurcated outlet 32. The maker in theform of an RFID 24 such as those of FIGS. 9 and 10 provides means todiscern pressure rating and is shown imparted on the top surface orengaged in a slot in the cap 21. There is an additional employed markershown on top of the septum 20 as lettering. However, a symbol notrequiring reading by a user can also be employed. As noted twodiscernible markers provide dual confirmation in all modes of the devicewithout an x ray or CT scan needed.

FIG. 8 shows a mode of the body 14 of the device employing an RFID 24 ina conventional capacity which when energized by the reader 41 transmitsa data from the RFID 24 and RAM or ROM or other means for electronicstorage engaged with the within the RIFD and located on the port body orcatheter engaged clip. The transmit and receive antennas for the RFID 24are shaped in the triangle symbol and are formed of metal adapted toreceive RF energy from the reader 41 so they appear on an x-ray as avisual symbol confirming pressure rating. This combination provides dualconfirmation of the pressure rating of the port without the need forexposing the patient to an x-ray or CT scan.

FIG. 9 depicts an energizable RFID 24 and other components configured toprovide a naked-eye-visible, or clearly audible signal identifying itspresence under a patient's skin. When energized by a reader 41 or otherRF emitted transmission, the LED may either employ energy generated fromthe passive RFID board using energy generated from the RF, or the LED 43or may have its own power supply and thereby be electronically activatedto switch on and illuminate which will be visible through the skin ofthe patient if mounted in position adjacent thereto, thereby providing avisibly discernible signal, through the skin of the patient, of thehidden underlying port's high pressure readiness, without an x-ray orscan.

In combination or as an alternative, energizing the RFID 24 mayconcurrently cause activation of an electronic sound generator toactivate a sonic alarm 45 such as a buzzer or beeper as well as an LED43 as well as the RFID 24. The multiple signaling componentconfiguration of the device 10 may be employed on any of the portsherein. This provides, in one pass, a triple certification of highpressure readiness.

FIG. 10 shows an RFID 24 having antennas 29 configured in segments toyield a triangular shape on an X-ray thereby providing the nonalphanumeric symbol, which would be visible on X-ray to identify theport. The RFID 24 is shown with the LED 43 and alarm 45. It isparticularly preferred in all modes of the device herein, that the RFID24 be MRI-safe in that ferrous metal is minimized or eliminated from thestructure. Consequently, it is particularly preferred that the antennas29 and larger portions of the RFID 24 is formed of substantially nonferrous metal which will not be moved or dismounted by the forces of anMRI such as aluminum, copper, titanium or an alloy, tin, or nickel.These metals will not be attracted to the magnetic force, and will notheat substantially and will generally alone or in combinations andalloys receive and transmit a sufficient signal to and from the RFID.

As noted earlier, the RFID 24 may be placed on the catheter securementclip, to allow attachment to the port without attaching to the wallsforming it which can cause damage during manufacture or long termstorage which might not be noticed and potentially cause harm to apatient if such a wall failed during use.

As additionally noted, the RFID 24 may include a wideband broadcastantenna 29 for broadcasting upon multiple frequencies with one or aplurality of RF data streams, employing frequencies such as thoseassociated with bluetooth and Wi-Fi transmissions. When energized by RF,the RFID would transmit information stored in ROM on the RFID 24concerning the nature of the port. This dual broadcast may also beemployed as a fail safe or as a means for transmission of a plurality ofdata streams about the device which will allow the RFID 24 tocommunicate for instance with a physician's medical record databaseconfigured to receive transmitted identification data, or a visualdisplay means such as a computer or smartphone having software adaptedto receive the information broadcast from the ROM or RAM of the RFID andconvert it to a displayed image on the screen thereof.

FIG. 11 shows an overhead view of a port device employing the clip 21engaged upon the catheter 34 and having an RFID 24 on or in a cavity inthe clip 21 where such positioning will avoid potential damage ofplacing a marker on the body of the port and will also position itbetter to transmit and receive RF energy. The RFID 24 is as in FIG. 9and a triangular marker is shown on another planar side of the clip.

FIG. 12 depicts a port device having an RFID 24 such as that of FIG. 10having one or both antennas 29 configured with segments yielding thedepiction of triangles which are visible on X-ray to confirm pumppressure ratings. The RFID 24 is also shown with the LED 43 and alarm45. As noted, any of the audio, visual, or other discernable markersshown or describe herein, may be employed singularly or in combinationwith any other one or plurality of such markers.

While all of the fundamental characteristics and features of thedisclosed device and method herein have been described herein, withreference to particular embodiments thereof, a latitude of modification,various changes and substitutions are intended in the foregoingdisclosure and it will be apparent that in some instance, some featuresof the invention will be employed without a corresponding use of otherfeatures without departing from the scope of the invention as set forth.It should be understood that such substitutions, modifications, andvariations may be made by those skilled in the art without departingfrom the spirit or scope of the invention. Consequently, all suchmodifications and variations are included within the scope of theinvention as defined herein.

1. A method for marking an implantable injection port comprising thestep of: engaging a marker formed of material which is clearlydiscernable in an X-ray image, to said injection port.
 2. The method ofclaim 1 additionally comprising the step of: engaging said marker from aplurality of said markers each of which has a non alphanumeric shapewhich is clearly discernable from the others in said plurality, in saidx-ray image; forming a lookup table of respective shapes of each saidmarker in said plurality and matching a respective pressure rating toeach respective said shape; with said injection port implanted in apatient, discerning said respective shape of a said marker in said x-rayimage of said injection port while implanted; matching said discernedrespective shape of said marker in said x-ray image to a respectivematching image shape in said lookup table; ascertaining a pressurerating of said injection port implanted in said patient by discerningthe respective pressure rating related to said respective matching imageshape in said lookup table matching said shape of said marker in saidx-ray image; and providing means for users speaking any language, toascertain a said pressure rating of said injection port without alanguage translation through the employment of said non alphanumericmarkers to ascertain a pressure rating of said implanted port,
 3. Themethod of claim 2, additionally comprising the steps of: employingsoftware adapted to the task and running on a microprocessor, toidentify said discerned respective shape of said marker in said x-rayimage; employing said software to ascertain, from said lookup table ofpressure ratings matched to respective marker images, a determined saidpressure rating for said marker so identified; and employing saidsoftware to take an action to prevent an injection from a communicationto said injection port, should said determined pressure rating of saidimplanted pressure port be less than a required injection pressurerating.
 4. The method of claim 2 additionally comprising the step of:placing an RFID in an engaged position on a body of said injection portor a clip configured to engage upon a lumen outlet of said port;programming electronic memory of said RFID with identificationinformation about a pressure rating of said injection port;communicating RF energy to said injection port when implanted in apatient to generate a transmission of said identification information;and employing said transmission to discern said pressure rating.
 5. Themethod of claim 4 additionally comprising the step of: engaging one or aplurality of additional port identifiers which allow an identificationof a said injection port while implanted in a patient from a group ofadditional port identifiers including, a light source activated to anilluminated state to communicate light through the skin of said patientby said RF transmission and, a buzzer activated to communicate soundthrough the skin of said patient by said RF transmission.
 6. Aninjection port for implantation under the skin of a patient, comprising:a body having an injectable reservoir for receiving fluid from ainjection through a septum covering said reservoir; a first marker in acommunicating mount with said injection port, said first marker formedof a marker material which is clearly discernable for shape fromsurrounding material in an X-ray image of said port when implanted in apatient; and said first marker when viewed upon said x-ray image of saidinjection port, providing means to discern a pressure rating of saidinjection port, without removing said pressure port from saidimplantation.
 7. The injection port of claim 6 additionally comprising:said first marker formed of a nonferrous material including one or acombination of marker materials from a group including, nonferrousmaterials including nitenol, tungsten, titanium, stainless steel,teflon, silicone nitride, Zirconium, gadolinium oxysulfide, and inksformed of a bio-compatible carrier and one or a combination of saidmarker materials; and the employment of such non-ferrous markermaterials singularly or in combination providing means to minimizeinteraction of said injection port while implanted, with radiated energyduring an MRI.
 8. The injection port of claim 7 additionally comprising:said first marker having a non alphanumeric shape clearly identifiablein said x-ray image; and said shape discernible to indicate a pressurerating for said injection port to viewers speaking and reading anylanguage.
 9. The injection port of claim 6 additionally comprising: asecond marker being an RFID having electronic memory and a dataprocessor configured to broadcast port identification information whenenergized from outside a patient's body by RF; and a receiving deviceconfigured to receive said broadcast port information and provide avideo display discernible by a user to ascertain said portidentification information.
 10. The injection port of claim 7additionally comprising: a second marker being an RFID having electronicmemory and a data processor configured to broadcast port identificationinformation when energized from outside a patients body by RF; and areceiving device configured to receive said broadcast port informationand provide a video display discernible by a user to ascertain said portidentification information.
 11. The injection port of claim 8additionally comprising: a second marker being an RFID having electronicmemory and a data processor configured to broadcast port identificationinformation when energized from outside a patients body by RF; and areceiving device configured to receive said broadcast port informationand provide a video display discernible by a user to ascertain said portidentification information.
 12. The injection port of claim 9additionally comprising: one or a plurality of supplemental markers froma group of supplemental markers including, an LED in electricalcommunication with said RFID which illuminates to communicate lightthrough the patient's skin when said RFID is energized by said RF, anelectronic sound generator in electrical communication with said RFIDwhich communicates a sound through the patient's skin when said RFID isenergized by said RF, a shape of an antenna engaged to said RFID, saidantenna shape discernible in an x-ray to identify a pressure rating forsaid pressure port, and said RFID configured to broadcast identificationinformation to a receiving display device when energized by said RF. 13.The injection port of claim 10 additionally comprising: one or aplurality of supplemental markers from a group of supplemental markersincluding, an LED in electrical communication with said RFID whichilluminates to communicate light through the patient's skin when saidRFID is energized by said RF, an electronic sound generator inelectrical communication with said RFID which communicates a soundthrough the patient's skin when said RFID is energized by said RF, ashape of an antenna engaged to said RFID, said antenna shape discerniblein an x-ray to identify a pressure rating for said pressure port, andsaid RFID configured to broadcast identification information to areceiving display device when energized by said RF.
 14. The injectionport of claim 11 additionally comprising: one or a plurality ofsupplemental markers from a group of supplemental markers including, anled in electrical communication with said RFID which illuminates tocommunicate light through the patient's skin when said RFID is energizedby said RF, a electronic sound generator in electrical communicationwith said RFID which communicates a sound through the patient's skinwhen said RFID is energized by said RF, a shape of an antenna engaged tosaid RFID, said antenna shape discernible in an x-ray to identify apressure rating for said pressure port, and said RFID configured tobroadcast identification information to a receiving display device whenenergized by said RF.